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What is the standard ivermectin dose for humans in mg/kg and approved indications (e.g., 2006–2024 guidance)?
Executive Summary
The available analyses converge on a clear conventional dosing range: ivermectin is typically dosed at 150–200 micrograms per kilogram (µg/kg) as a single oral dose for most established human indications, with specific regimens varying by disease (onchocerciasis commonly 150 µg/kg; strongyloidiasis commonly 200 µg/kg) and repeated dosing schedules used for public-health programs (mass drug administration) [1] [2] [3]. Regulatory guidance and recent WHO/EMA work emphasize approved parasitic indications—onchocerciasis, strongyloidiasis, scabies and selected soil-transmitted helminths—while warning against unapproved uses outside trials; pediatric formulation and pharmacokinetic work from 2024 suggest targeted adjustments (e.g., 250 µg/kg in a child-friendly study) to match exposures in young children [4] [5] [6].
1. Why 150–200 µg/kg has become the clinical norm — the dosing story that clinicians rely on
Clinical and drug-label sources repeatedly state a weight-based single dose of 150–200 µg/kg as the standard human regimen across major parasitic infections, with tables and tablet sizes (commonly 3 mg tablets) used to translate that into pill counts for practice [1] [2]. For onchocerciasis, the common practice is 150 µg/kg, often repeated every 3–12 months in endemic control programs; for strongyloidiasis, the guidance centers on 200 µg/kg as a single or sometimes repeated dose. Package labeling and clinical summaries emphasize careful weight calculation, contraindications, and monitoring for adverse effects—the margin between therapeutic and toxic effects is managed by weight-based dosing and clinical follow-up [7] [2]. These sources form the backbone of 2006–2024 clinical guidance and mass-treatment practice in endemic settings [3].
2. Regulatory and WHO positions — where approvals and public-health policy align and diverge
Regulatory agencies and the WHO focus approval and programmatic recommendations on parasitic diseases: onchocerciasis, strongyloidiasis, lymphatic filariasis (as part of co-administration programs), scabies, and certain soil-transmitted helminths are the primary indications described across 2017–2025 guidance summaries and EMA/WHO evaluations [3] [6]. WHO 2024 guidance explicitly addresses preventive chemotherapy for strongyloidiasis at a programmatic level but does not replace clinical weight-based dosing listed elsewhere; the EMA worked with WHO on ivermectin/albendazole combinations for use outside EU settings [5] [6]. Regulatory statements also consistently warn against off-label use (notably for COVID-19) outside randomized trials, reflecting safety and evidence limitations in non-parasitic indications [8].
3. Pediatric dosing and formulation debates — new evidence pushing the envelope
A 2024 pharmacometrics study evaluated a child-friendly formulation and found that 250 µg/kg in that formulation yielded exposure equivalent to adults receiving 200 µg/kg, highlighting that standard adult-derived mg/kg regimens may underdose small children when tablets cannot be accurately split [4]. This work supports development of pediatric formulations and suggests programmatic dosing for children under 15 kg may require adjustment to achieve therapeutic exposure. WHO program guidance recognizes the need to tailor preventive chemotherapy strategies for children in endemic areas, while regulatory evaluations in 2025 considered combination products for broader public-health use [5] [6]. These findings indicate the clinical norm (150–200 µg/kg) remains valid for many patients but pediatric-specific pharmacokinetics demand ongoing refinement.
4. Safety, off-label controversies, and limits of the evidence base
Safety summaries indicate ivermectin is generally well tolerated at authorized doses used for parasitic infections, with adverse effects including dizziness, abdominal pain, and rash, and rare interactions [7] [9]. Multiple sources and regulatory bodies caution against higher or repeated dosing outside established indications and clinical trials, and the EMA explicitly advised against using ivermectin for COVID-19 outside trials because of insufficient evidence [8]. Older and broader reviews highlight ivermectin’s wide therapeutic applications in parasitology but also emphasize that mechanistic uncertainty and emerging resistance concerns motivate continued monitoring and conservative approval for non-parasitic uses [3] [7].
5. Bottom line for clinicians and public-health planners — apply weight-based norms, note exceptions
For routine clinical practice and endemic-program implementation from 2006 through 2024, adopt 150 µg/kg for onchocerciasis and 200 µg/kg for strongyloidiasis as standard single-dose regimens, using tablet strengths to calculate pill numbers and repeating doses per disease-specific protocols or mass-treatment schedules [1] [2] [3]. Recognize emerging pediatric data [10] that advocate higher per-kg dosing or pediatric formulations to match adult exposures in small children, and follow WHO/EMA regulatory statements when implementing public-health campaigns or considering combination therapies [4] [5] [6]. Avoid unapproved uses outside randomized trials and consult current national formularies for country-specific approved indications and dosing details [8] [7].